Kornimate/medical-research-clean huggingface dataset:
anakinra to prevent post-infarction remodeling

Conditions: ST Segment Elevation Acute Myocardial Infarction

Summary: thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, ami). patients surviving ami remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart). current interventions proven to reduce adverse remodeling and progression to heart failure include early reperfusion (restoring blood flow to the heart muscle) and long-term use of medicines that block the effects of hormones (such as angiotensin ii, norepinephrine and aldosterone) involved in adverse remodeling. despite these treatments, however, many patients continue to develop heart failure within 1 year of ami. these patients are at very high risk of death. numerous changes occur in the hearts of patients after ami that lead to adverse remodeling. ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (il-1) production in the heart. il-1 plays a critical role in adverse cardiac remodeling by coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway (leading to cell death). in opposition to il-1 activity, the human body produces a natural il-1 receptor antagonist that blocks the effects of il-1. the drug form of this il-1 receptor antagonist (anakinra) is currently fda approved for the treatment of rheumatoid arthritis, an inflammatory disease characterized by excessive il-1 activity. experimental studies show that anakinra is able to prevent cardiac remodeling and improve survival in mice after ami. we hypothesize that anakinra will show similar benefits in human patients by preventing adverse remodeling and heart failure after ami.


Eligibility criteria:
inclusion criteria: * age \>18 years * acute (\<24 hours) onset of chest pain * new or presumably new st elevation on ecg * planned coronary angiography for percutaneous revascularization exclusion criteria: * inability to give informed consent * late presentation (\>24 hours) * unsuccessful revascularization or urgent coronary bypass surgery * hemodynamic instability * end-stage congestive heart failure (aha/acc stage c/d, nyha class iv) * preexisting severe lv dysfunction (lvef\<20%) or severe valvular disease * severe asthma * pregnancy ( pre-enrollment pregnancy test) * contraindications to cardiac mri or cardiac angiography * severe coagulopathy (inr\>2.0, platelet count\<50,000/mm3) * severe renal insufficiency (creatinine clearance \<30 ml/min/m2) * recent (\<14 days) use of anti-inflammatory drugs (nsaids excluded) * chronic inflammatory disease

Keywords: acute myocardial infarction
cpp versus pfc to correct coagulation disorders in adult neurosurgical patients

Conditions: Intracranial Hemorrhages

Summary: this prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (pt value less than 60%).

the coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. they are diagnosed more often in emergency on a pt value less than 60% and so they should be corrected as soon as possible. two therapeutic strategies are proposed by french or international recommendations: transfusion of fresh frozen plasma (ffp) or administration of prothrombin complex concentrates (pcc). this prospective, randomized, multicenter study with blinded assessment of the primary endpoint, is performed to determine whether pcc confers any benefits over ffp in the neurological patients with coagulation disorders.

Eligibility criteria:
inclusion criteria: * patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery * coagulation disorder defined by pt less than 60% exclusion criteria: * concomitant use with oral anticoagulant drugs * acquired deficiency of coagulation factors whose treatment is established * hypersensitivity to a pcc * history of thrombocytopenia induced by heparin * disseminated intravascular coagulation * extracranial active bleeding * hypersensitivity to vitamin k
web-based rehab after acute vertigo

Conditions: Acute Vestibular Syndrome

Summary: acute onset vertigo is common and entails much suffering with persisting symptoms at 3 months after onset in up to half of those afflicted. vestibular rehabilitation to aid recovery is not readily available. the purpose of this study is to investigate the effects on vertigo symptoms of a 6-week online vestibular rehabilitation tool compared with standard care (written instructions leaflet) after acute onset vertigo.


Eligibility criteria:
inclusion criteria: * ≥18 years old; and * the subject has given written consent to participate in the study; and * new acute onset dizziness or vertigo since ≥24 hours with pathological spontaneous or gaze-evoked nystagmus (i.e. an acute vestibular syndrome, avs). the nystagmus as described above must be present at investigation between 24 hours and 7 days from onset, spontaneously, gaze-evoked or head-shake evoked and documented; and * screening and inclusion within 7 days of onset of continuous symptoms; and * symptomatic at inclusion exclusion criteria: * pre-existing vestibular disease or neurological disease anticipated to affect the ability to participate in the study or the effect of the intervention. n.b: recurring avs with no set diagnosis before inclusion is accepted, as is past transient neurological diseases such as tia or migraine; or * inability to use the online rehabilitation tool, e.g. due to not having access to a computer, tablet or smartphone, not having access to the internet or lacking in experience with such tools; or * mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; or * medical and/or physical contraindications to making the required head movements (e.g. vertebral dissection) or otherwise participating in the training and testing exercises or data collection; or * medication or other substance intake which can affect the ability to participate in the study or the reliability of the measurement methods. these medications include regular use of: anticonvulsants, antiemetics/motion sickness medications, benzodiazepines, neuroleptics. transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.

Keywords: acute vestibular syndrome vertigo vestibular rehabilitation
ultrasound guided quadratus lumborum block versus transversus abdominis plane block as postoperative analgesia in patients undergoing abdominal cancer surgery.

Conditions: Abdominal Cancer

Summary: abdominal surgery is usually associated with severe postoperative pain. the transverse abdominal plane (tap) block is considered an effective means for pain control in such cases. the quadratus lumborum (ql) block is another option for the management of postoperative pain. the aim of this study is to evaluate the efficacy and safety of quadrates lumborum blocks and transversus abdominis plane blocks for pain management after abdominal cancer surgery.

postoperative pain is severe in patients undergoing abdominal surgery, and severe pain not only affects the rate of recovery of patients but also induces a series of pathophysiological reactions. therefore, it is very important for perioperative patients to have a safe and effective pain management model. although classic postoperative analgesia methods can provide effective pain relief after surgery, their administration has a well-defined risk of side effects. recently, with the rise in enhanced recovery after surgery, nerve blocks have become the key link in multimodal analgesic regimes. as effective constituents of multimode analgesia, quadratus lumborum (ql) block and transversus abdominis plane (tap) block are mainly used for postoperative analgesia in abdominal surgery. aim of this study is to compare between the analgesic effecacy of quadrates lumborum block and transverses abdominal plane block

Eligibility criteria:
inclusion criteria: * patients included in the study, aged 20-60 years, * with asa physical status class i and ii, * scheduled for abdominal cancer surgery under general anesthesia exclusion criteria: * infection at injection site, * allergy to local anesthetics, * coagulation disorders, * physical or mental diseases which could interfere with the evaluation of pain scores * kidney failure or liver failure.
a study to compare efficacy and safety of ct-p47 and roactemra in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase 3 study to compare efficacy and safety of ct-p47 and roactemra in patients with moderate to severe active rheumatoid arthritis.

ct-p47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to roactemra/actemra. the purpose of this study is to demonstrate similar efficacy and safety of ct-p47 and roactemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility criteria:
inclusion criteria: 1. patient is male or female aged 18 to 75 years old, both inclusive. 2. patient has had a diagnosis of ra according to the 2010 acr/eular classification criteria for at least 24 weeks prior to the first administration of the study drug. exclusion criteria: 1. patient who has previously received investigational or licensed product; targeted synthetic dmard(s) (e.g., tofacitinib, baricitinib) for the treatment of ra and/or an interleukin-6 (il-6) inhibitor for any purposes. 2. patient who has previously received more than 1 biologic agents approved for the treatment of ra. 3. patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
role of mineralocorticoid receptor in diabetic cardiovascular disease

Conditions: Type 2 Diabetes Mellitus; Vascular Disease

Summary: aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin converting enzyme inhibitors or angiotensin ii (angii) receptor blockers. this study will test the hypothesis that mineralocorticoid receptor (mr) antagonists exert beneficial cardiovascular effects, specifically by decreasing vascular injury and improving vascular function. a randomized, double-blind study will be conducted, in which participants with type 2 diabetes mellitus will undergo a series of assessments to test heart, blood vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of the following drugs: 1. spironolactone 2. hydrochlorothiazide (hctz) plus potassium 3. placebo in the event of insufficient funds, randomization to the placebo arm will be stopped and primary assessment of outcomes will occur at baseline and after 6 months of treatment.


Eligibility criteria:
inclusion criteria: * age 18-70 years * type 2 diabetes mellitus * with or without hypertension exclusion criteria: * ischemic changes on resting electrocardiogram, * clinical evidence of heart disease (angina, heart failure, unstable angina),cerebrovascular or peripheral vascular disease, * significant cardiac arrhythmias, * aortic stenosis, * 2nd or 3rd degree atrio-ventricular block, sinus node disease, or symptomatic bradycardia, * bronchospastic lung disease with active wheezing, * known hypersensitivity to adenosine, * hemoglobin a1c (hba1c) \> 8.5%, \* * gout (if not already taking hctz), * the use of rosiglitazone,\*\* * estimated glomerular filtration rate (egfr) \< 60 ml/min, * serum potassium \> 5.0 mmol/l, * use of potassium-sparing diuretics,\*\* * current smoker,\* * pregnancy, * renal disease not related to diabetes mellitus, * uncontrolled hypertension, systolic blood pressure (bp) \>160 mm hg and diastolic bp \>100 mm hg,\* * use of cyclic hormone replacement therapy * past intolerance of angiotensin-converting enzyme (ace) inhibitor therapy * other major medical illnesses. participants with evidence of a previous myocardial infarction on the first adenosine-stimulated positron emission tomography (pet) study will be withdrawn from the study. * screening systolic blood pressure \< 105 mm hg off of anti-hypertensive medications * participants can enroll in study and proceed with in-patient evaluations if during the run-in period adjustments of medications, diet and habits lead to improved glucose control \[equivalent to hba1c \<8.5%, controlled hypertension and cessation of smoking. * participants who are currently taking these medications will not qualify for a screening visit. if medications were recently stopped by the participant's physician, he or she may be screened but the baseline assessment protocol must occur 3 months after stopping.
a study to assess yh003 in combination with pebolizumab and albumin paclitaxel injection in subjects with unresectable/metastatic mucosal melanoma

Conditions: Mucosal Melanoma

Summary: this study is a multicenter, single-arm, open-label phase ii study to assess the efficacy and safety of yh003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma.


Eligibility criteria:
inclusion criteria: * 1.subjects must have the ability to understand and willingness to sign a written informed consent document. * 2. subjects must have histologically advanced or cytologically confirmed metastatic or unresectable mucosal melanoma; * 3.subjects have not received standard systemic therapy; patients have disease progression 6 months or more after the end of neoadjuvant or adjuvant therapy (except nab-paclitaxel), and can be enrolled in the clinical study; * 4. subject must have at least 1 unidimensional measurable disease by recist 1.1; * 5. subjects must be age 18 years or older; * 6. subjects must have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * 7. life expectancy ≥3 months based on investigator's judgement； * 8. subjects must have adequate organ function; * 9. women of childbearing potential need to have a negative pregnancy test and need to take contraceptive/contraceptive measures including their partners. exclusion criteria: * 1.subjects have another active invasive malignancy within 5 years； * 2.the subject has received anti-tumor therapy or other investigational drug therapy or traditional chinese medicine (herbal medicine) with anti-tumor indications prior to the first dose; * 3.subjects with a history of ≥ grade 3 immune-related adverse events resulted from previous immunotherapy. * 4.history of clinically significant sensitivity or allergy ； * 5.primary central nervous system (cns) malignancies or symptomatic cns metastases.； * 6.history of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease； * 7.subjects have active pulmonary embolism with hemodynamic changes 12 weeks before the first dose; * 8. subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment; * 9. subjects have clinically uncontrolled diseases; * 10. subjects have severe cardiovascular disease; * 11. subjects have evidence of active infection; * 12. subjects must not have a known or suspected history of an autoimmune disorder； * 13.major surgery within 4 weeks prior to study entry and minor surgery within 2 weeks prior to the first dose. * 14. any condition that the investigator assesses as inappropriate for participation in the study.
visual cerebral connectivity on functional magnetic resonance imaging in patients with hereditary retinal dystrophies

Conditions: Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies

Summary: the rothschild foundation a hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. these patients are followed in ophthalmology consultation every year. in order to plan the mri on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). if patients agree to participate in the study, rmri will be scheduled. during the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique * artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months * express consent to participate in the study * affiliate or beneficiary of a social security scheme exclusion criteria: * patient benefiting from a legal protection measure * pregnant or breastfeeding woman * contraindication to mri (claustrophobia, implanted equipment such as pacemaker). * other additional ocular pathology that can significantly affect vision * recent eye surgery less than 3 months old
nutritional status and prognosis in heart failure.

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients.

despite obesity is a cardiovascular risk factor, numerous studies have identified a better prognosis in overweight and obese heart failure (hf) patients. this paradox has been named "the obesity paradox". however, this paradox has been criticized because the parameter used to classify obesity, the body mass index (bmi), has several limitations. obesity is defined as an abnormal or excessive fat accumulation, and bmi does not always reflect real body fat. what is more, patients with hf can have their body composition altered with hyperhydration or undernourishment. a pilot study proved that bmi does not indicate true nutritional status in hf. thus, a further assessment of body composition of hf patients, analyzing the nutritional status rather bmi, could shed light on the obesity paradox. the aim of this study was to assess the nutritional status of a cohort of hf patients, its correspondence with bmi, and its significance in terms of survival.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure according to the european guidelines of heart failure. * depressed lvef (\< 45%) or ≥ 1 hospital admission due to hf decompensation * outpatients \> 18 years of age, male or female, capable of giving an informed consent. exclusion criteria: * severe co-morbidity associated with a reduction in life expectancy of less than 1 year. * myopathy or other diseases that could cause significant sarcopenia beyond hf. * non-controlled hyperthyroidism

Keywords: malnutrition undernutrition nutrition assessment nutritional assessment nutritional index prognostic nutritional index prognostic nutritional index (pni) nutritional status prognosis heart failure cardiovascular diseases body composition body weights and measures
ave8062 in combination with platinum-taxane doublet in advanced solid tumor

Conditions: Neoplasms

Summary: the purpose of this study is to determine the recommended dose of the combination of ave8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.


Eligibility criteria:
inclusion criteria: * advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer. * eastern cooperative oncology group (ecog) performance status of 0 to 1. exclusion criteria: * concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study. * absence of histologically or cytologically proven cancer at the first diagnosis. * negative serum/urinary pregnancy test * washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: neoplasms antineoplastic combined chemotherapy protocol
non-comparative study to evaluate changes in fmd after quinapril therapy in hypertensive women

Conditions: Menopause; Hypertension

Summary: ace inhibitors are thought to modify the endothelium in a number of ways. quinapril is an effective and well-tolerated ace-i for the treatment of patients with hypertension and congestive heart failure. quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. these effects are mediated through the binding of quinaprilat to both tissue and plasma-ace. quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved fmd or reduced vasoconstrictive/increased vasodilative response to ach) in patients with cad and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with chf receiving a single infusion of quinaprilat. in general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) there are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.


Eligibility criteria:
inclusion criteria: * pathological baseline fmd (\< 5%) at screening * women in post-menopause at least for 2 years (post-menopausal defined as having amenorrhea for å' 2 years) * mild or moderate hypertension (bp \> 140/90 mmhg) exclusion criteria: * uncontrolled severe hypertension (bp \> 180/110 mmhg)